Failure of latest AIDS drugs

By Neville Hodgkinson – The Business, September 2006

Widespread belief that the latest drugs for fighting Aids are bringing down death rates from the syndrome have been confounded by a huge study covering 10 years of treatment and involving more than 22,000 patients in Europe and North America.

The study, reported in The Lancet last month, compared groups of HIV-positive patients started on highly active antiretroviral therapy (HAART) at different times between 1995 and 2003. The patients were followed for one year. Major findings are that although HAART appeared to be getting much better at reducing levels of virus, there was no corresponding decrease in overall death rates and the patients’ risk of developing or dying from Aids actually increased in recent years.

In a commentary on the study headed “HAART’s first decade: success brings further challenges”, Aids specialists say these “somewhat paradoxical” trends may be due to changing characteristics in the patients. Between 1995 and 2003, whilst the proportion of male homosexuals nearly halved, there were more patients with tuberculosis, probably among immigrants and refugees from countries where the disease is common.

Scientists have noted previously that TB patients can become immediately sicker when treated with anti-Aids drugs, a phenomenon they have termed “immune reconstitution disease”. The Lancet authors say this could have become more common due to use of more potent antiretroviral drugs.

They add however that this would not fully explain the study findings, since “the same trends in the rate of Aids were also present, although somewhat weaker, in men who have sex with men”. They also note that in all the risk groups, the time between starting on HAART and developing Aids decreased.

As well as being a blow to Aids doctors, the findings strengthen the hand of scientists who argue that by looking at supposed markers of HIV infection – and failing to demonstrate the presence of HIV itself – Aids science has gone seriously astray.

If patients with active TB, for example, test HIV-positive, they are held to be “co-infected” and suffering from Aids. Yet as reported in previous issues of The Business (9/10 and 16/17 May 2004 and 21/22 May 2006), “HIV” antibody tests have never been validated as specifying the presence of HIV. The same is true of so-called “viral load” tests.

There is also clear evidence that the bacterium which causes TB can itself cause people to test false positive for “HIV”. This raises the urgent question of whether TB should be included in the list of nearly 30 illnesses considered diagnostic of Aids, and sufferers treated with potent antiviral drugs for an infection they have not been proved to have. Since TB affects millions of malnourished people, removing it as an Aids-indicator disease would radically reduce estimates of HIV/Aids incidence in countries where many still live in poverty.

The findings also raise a wider question, of whether Aids drugs really save lives. Despite clear short-term benefits in some patients, HAART has never been shown in a scientific trial to be better than no treatment at all, by comparing the outcome in those receiving the active drugs with those given a placebo. This is despite a long-standing rule in medical science that “no researcher can assess a drug’s effectiveness with scientific certainty without testing it against a placebo”, as a leading Aids scientist has put it.

Responding to such concerns, Dr Margaret May, of Bristol University, the study’s main author, says: “Our paper only compares patients on HAART in different eras. It does not say that HAART does not reduce morbidity and mortality compared to no treatment, only that death rates have not decreased during the decade of HAART. This is likely due to changes in patient demographics, patients receiving treatment too late to get the full benefit, more co-infection with other diseases etc.”

May says “it would not be ethical” to compare HAART with a placebo, since there was “much evidence that HAART is very effective in preventing Aids and death in patients with HIV-infection compared with no treatment…Death rates are much less in the HAART era (post 1996) compared with the pre-HAART era.”

Critics respond however that a fall in death rates from Aids when HAART was introduced came about partly because of a huge expansion in the mid-1990s in the number of “Aids” patients, including many who had no symptoms of disease, because of a widening of the definition of the disease; as well as because of drastic reductions in doses of Aids drugs such as AZT amidst clear indications that these could be lethal.